Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis

Magnetic Resonance Imaging Clinical Trial

— NEFIMAR  

Official title:

Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01777451
• Other study ID #: NEFIMAR
• Secondary ID: S52684
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2013
• Last updated: January 23, 2013
• Start date: December 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Steven Pans, MD
• Phone: 3216340505s
• Email: steven.pans[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial Summary

Whole body MRI will be performed in patients with neurofibromatosis Type 1

PURPOSE 1:

To determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or malignant peripheral nerve sheath tumors. All patients will be scanned two years after the baseline whole body MRI to investigate to investigate the changes of total tumor load.

PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas

PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath tumors and neurofibroma.

PURPOSE 4 : correlation between histopathology of the surgically resected neurofibroma/malignant nerve sheath tumors and MRI findings

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with neurofibromatosis type 1, between 6 and 50 years old

Exclusion Criteria:

• Patients who are not allowed to be scanned on MRI (contra-indications: pacemaker ed.)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diffusion Magnetic Resonance Imaging
• Magnetic Resonance Imaging
• Nerve Sheath Neoplasms
• Neurilemmoma
• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Peripheral Nerve Sheath Tumors, Malignant
• Whole Body Imaging

Intervention

Other:
• Additional imaging or surgery
No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Cai W, Kassarjian A, Bredella MA, Harris GJ, Yoshida H, Mautner VF, Wenzel R, Plotkin SR. Tumor burden in patients with neurofibromatosis types 1 and 2 and schwannomatosis: determination on whole-body MR images. Radiology. 2009 Mar;250(3):665-73. doi: 10.1148/radiol.2503080700. — View Citation

Tucker T, Friedman JM, Friedrich RE, Wenzel R, Fünsterer C, Mautner VF. Longitudinal study of neurofibromatosis 1 associated plexiform neurofibromas. J Med Genet. 2009 Feb;46(2):81-5. doi: 10.1136/jmg.2008.061051. Epub 2008 Oct 17. — View Citation

Van Meerbeeck SF, Verstraete KL, Janssens S, Mortier G. Whole body MR imaging in neurofibromatosis type 1. Eur J Radiol. 2009 Feb;69(2):236-42. doi: 10.1016/j.ejrad.2008.10.024. Epub 2008 Dec 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of total tumor load and diagnosis of high-risk neurofibromas	Estimation of the total tumor load of neurofibromas with whole body MRI (head to knee). Diagnosis of high risk neurofibroma in the chest, abdomen, pelvis, and extremities with T2-weighted sequence and diffusion weighted sequence.	1 month	No
Secondary	To diagnose high-risk neurofibroma	Some patients with neurofibromatosis have lesions, pre-malignant or malignant neurofibromas. Additional imaging (PET-CT), a biopsy or surgical treatment is necessary in combination with histopathology of the lesion.	2 months	No